Floré Microbiome Testing and Probiotics Informed Consent
You areparticipating in a microbiome analysis service through Floré by Sun Genomics,in partnership with a certified CLIA laboratory. The following consent detailsyour rights, responsibilities, and the nature of the services being provided.Your consent is required for the microbiome test, data sharing, and preparationof personalized probiotics.
1. Microbiome Testing through a Third-Party Laboratory:
You understandthat the microbiome test is being provided by a third-party CLIA-certifiedlaboratory. The laboratory has met all applicable federal and state standardsrequired to perform laboratory testing on human samples. The purpose of thistest is to analyze your gut microbiome's composition, which includes theidentification of bacteria, fungi, and other organisms present in your gut. Thetesting does not involve a clinical diagnosis and should not be interpreted asmedical advice. The lab will conduct this test, and your sample will beprocessed in accordance with industry standards and applicable regulations.
2. Authorization for Data Sharing:
By providing yoursample, you authorize the CLIA-certified laboratory to share the raw microbiomedata with Sun Genomics, the company operating under the Floré brand. The rawdata from your test will include microbial species, abundance, and other informationpertinent to the analysis of your microbiome. This data will be used solely forcreating your personalized probiotic formula and will not be used for any otherpurpose without your consent. The transfer of data will comply with allapplicable data protection laws, including HIPAA. Your data will remainconfidential and protected during this process.
3. Analysis and Background of Testing:
The testingperformed by our CLIA-certified lab partner involves Whole Genome Sequencing(WGS) technology. This advanced sequencing method allows us to thoroughlyanalyze the microbial composition of your gut based on the sample provided andon the time of sampling. The results from this test will identify the names andquantities of each microorganism, such as bacteria and fungi, in your gut.Beyond this, the analysis also describes your microbiome capacity, which refersto your microbiome's ability to generate essential nutrients, vitamins, andother beneficial molecules that support your overall health.
4. Stool Sampling Process:
The microbiometest is performed using a stool sample that you will provide. A stool testinvolves collecting a small sample of your feces in a provided sterilecontainer, which will be sent to the laboratory for analysis. Stool tests arecommonly used in microbiome research because they offer a direct way to studythe gut’s microbial ecosystem. The microorganisms in your gut play a crucialrole in digestion, immunity, and other health-related functions, which makesthis type of analysis important for understanding your unique microbiome.
5. Personalized Probiotic Request:
Should you electto continue following your test into a probiotic formulation, you authorizeFloré by Sun Genomics to receive data to support the formulation process. Thisformulation uses your microbiome data to formulate a personalized probioticsolution. This probiotic will be customized based on the unique bacterialcomposition of your microbiome. The objective of this personalized approach isto support your gut health through a tailored probiotic regimen that reflectsyour specific microbiome signature. By agreeing to this service, youacknowledge that the preparation of personalized probiotics is based ondescriptive data from your microbiome and is designed to support wellness, notto treat, diagnose, or cure any medical conditions.
6. Non-Diagnostic Nature of Testing:
You acknowledgethat the microbiome test you are undergoing is for descriptive purposes onlyand is not intended to diagnose or treat any medical conditions. The resultsprovided will describe the types and relative abundance of microorganisms inyour gut but do not serve as a clinical diagnosis. This information is intendedto help inform lifestyle choices and wellness strategies. You understand thatthis testing should not replace professional medical advice, and any concernsor conditions related to your health should be discussed with a licensedhealthcare provider.
Applicable Laws and Privacy:
Sun Genomics,Floré, and their partners comply with federal and state regulations, includingHIPAA, ensuring the privacy and security of your health data. Your test resultsand raw data will be handled with the highest level of confidentiality. TheCLIA laboratory, Sun Genomics, and any authorized personnel will only haveaccess to your data for purposes directly relatedto your test and probiotic formulation. No third parties will access your datawithout your express written consent. For EU residents, the General DataProtection Regulation (GDPR) will apply, ensuring further protection of yourpersonal health information.
Acknowledgement and Consent:
By signing below, you confirm that you have read and understood the information in this consent form, that you have had the opportunity to ask questions, and that you voluntarily consent to the microbiome testing, data sharing, and preparation of personalized probiotics by Floré.